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ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators


Representing a compromise in the pharmaceutical industry in balancing patent exclusivity against market competition, the effect of the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act) on controlling the pharmaceutical market remains unsettled. Amendments to the original act included provisions for an abbreviated process for FDA approval of generic versions of patented pharmaceuticals through the filing of an Abbreviated New Drug Application (ANDA) and the right to initiate patent litigation against an applicant. This law has resulted in ANDA litigation cases and a constant struggle to shape the landscape of the patent and regulatory regime governing FDA approved patented and generic drugs.

The Hatch-Waxman Act with it amendments is a hybrid of two already complex areas of the law -- U. S. patent law and FDA regulatory law -- which makes patent litigation in this area especially complicated and hotly contested. ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators examines the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation. 

Keker & Van Nest attorneys Asim Bhansali, Paula Blizzard and Sharif Jacob authored the book's chapter on Antitrust issues. Their chapter includes:

  • An Overview of Antitrust Issues
  • Legal Theories in ANDA Antitrust Cases
  • Federal Trade Commission Cases
  • Private Cases
  • Remedies

About the Authors

Asim Bhansali has extensive trial and litigation experience in antitrust, intellectual property, and complex commercial matters. His antitrust cases span a range of high-technology, financial, and life-science industries, and have included several of the largest private civil actions in U.S. history. Mr. Bhansali has defended clients in consumer class actions, including alleged violations of California unfair competition laws. His intellectual property cases have included patent and trade-secret actions in the pharmaceutical, computer-software, internet, and semiconductor industries.

Paula Blizzard's practice focuses on complex business litigation and criminal matters, including antitrust and patent cases. Before joining Keker & Van Nest, Ms. Blizzard served as special counsel for the U.S. Department of Justice’s Antitrust Division in San Francisco, where she reported directly to the assistant attorney general for antitrust in Washington, D.C.

Sharif Jacob focuses on complex litigation, including commercial disputes and white collar criminal cases. Mr. Jacob has represented businesses, unions, and individuals in cases involving patent infringement, securities fraud, insider trading, breach of contract, broker-dealer violations, environmental torts, and intra-union disputes.